ETHOCEL™

SDSs issued by IFF in Europe are in compliance with all applicable European legislation requirements, including REACH requirements as interpreted by the European Commission. 

Due to practical challenges of implementing the SDS changes required by REACH before the start of the Registration process, the European Commission supported the CEFIC position with respect to the following key points:

The only requirements that could reasonably be implemented by June 1, 2007 were mainly format changes.

(These include reversing the content of Sections 2 and 3, inserting the e-mail address of the individual responsible for creating the SDS in Section 1, and for substances not classified as dangerous, adding the reason for indicating the substance in Section 3).

SDSs that do not need to be revised for reasons other than the above format changes can stay in the pre-REACH format and are considered to be still in compliance because their content is correct. For newly created SDSs, and for revised SDSs, the format changes must be implemented.

All changes required by REACH as described in articles 31 and Annex II of the Regulation should be implemented before Dec 1, 2010, which coincides with the first deadline for registration. Until that date, the SDSs circulating in Europe will be in 2 different formats.

IFF has implemented the above recommendations of the European Commission. On this basis, our SDSs comply with the REACH requirements as currently defined and interpreted by the European Commission.

ETHOCEL is a trademark of IFF for its family of thermoplastic cellulose ethers.  These polymers have provided excellent service to industry since their commercial introduction by Dow in the mid-1930s.

These multifunctional, water-insoluble, organosoluble polymers are used in many pharmaceutical and specialty applications.  They function as binders; tough, flexible film formers; masking and time-release agents; water barriers; and rheology modifiers, to name a few.

General Properties - ETHOCEL ethylcellulose polymers are colorless, odorless, tasteless, and noncaloric.  They have outstanding chemical and  physical properties.  These properties make them useful in many applications - from pharmaceutical, food, and personal care applications to specialty applications, including some of the most sophisticated electronic devices.1

Flammability - Once ignited, ETHOCEL will support combustion. However, ETHOCEL offers no greater fire hazard on storage and handling than does paper or cellulose in the same physical form.

Thermal Stability - ETHOCEL is stable up to its melting point (~160°C, 320°F). The viscosity of ETHOCEL™ polymers is stable to high temperatures. It has good outdoor durability and toughness at both high and low temperatures.

Low Ash Content - ETHOCEL has a very low ash content, making it useful in applications such as conductive inks and pastes, dielectrics, ceramics, and fluorescent lighting.

Stability to Light - ETHOCEL does not discolor on exposure to strong sunlight nor does it promote the discoloration of plasticizers or polymers.

Chemical Stability/Resistance - ETHOCEL is a stable, slightly hygroscopic material. It is inert to attack by aqueous alkalies, even when hot and highly concentrated. It is resistant to salt solutions and resists oxidation below its softening temperature.

Thermoplasticity - ETHOCEL possesses excellent thermoplasticity.  Unplasticized ETHOCEL softens and becomes plastic at 135°C to 160°C Softening point and metling point temperatures.  It can be compounded with plasticizer, waxes, and polymers while in a plastic condition.  Plasticized ETHOCEL™ softens at much lower temperatures than unplasticized ETHOCEL and forms the basis of compositions for molding, extruding, and laminating uses.

Flexibility - Films made from ETHOCEL polymers are highly flexible and retain their flexibility at temperatures well below freezing.

Film Formation - ETHOCEL is an excellent film former. Films made from ETHOCEL are tough, with high tensile strength and an unusual degree of flexibility even at low temperatures. ETHOCEL polymers yield a greater volume of film-forming solids than any other cellulose derivative.

Compatibility - ETHOCEL™ is compatible with most common plasticizers and polymers. It yields clear films with a wider variety of plasticizers and polymers than any other cellulose derivative.

Water Resistance - ETHOCEL is an excellent water barrier. Films of ETHOCEL absorb little moisture either on exposure to the atmosphere or after long immersion in water.

Binding - The good binding qualities of ETHOCEL are useful in applications such as tableting and microencapsulation.

Controlled Release - ETHOCEL allows control of the release of active ingredients from solid dosage forms.

Solubility - ETHOCEL dissolves in a wide range of solvents such as aliphatic alcohols, chlorinated solvents, and natural oils. It is practically insoluble in glycerin, propylene glycol, and water.

1All applications may not be suitable for all regions

To learn more about this product line please view our website on ETHOCEL.
 

All of IFF's businesses are committed to improving the environment, health, and safety of our workers, our operations, our products, our customers' use of our products, and the communities and countries where we manufacture and market.  IFF's EH&S Policy states:

At IFF, protecting people and the environment will be part of everything we do and every decision we make.  Each employee has a responsibility in ensuring that our products and operations meet applicable government or Dow standards, whichever is more stringent.

Our goal is to eliminate all injuries, prevent adverse environmental and health impacts, reduce wastes and emissions and promote resource conservation at every stage of the life cycle of our products.  We will report our progress and be responsive to the public.
 
IFF complies with the American Chemistry Council's Responsible Care® guiding principles, codes, and management system requirements. DuPoint has recommitted its support for Responsible Care on a global scale by signing the Responsible Care Global Charter under the auspices of the International Council of Chemical Associations (ICCA).  IFF has also endorsed the ICCA's Global Product Strategy, an effort by the global chemical industry to further improve its product stewardship efforts.  Our EH&S management system is audited regularly to ensure compliance with all applicable governmental requirements, Responsible Care, ISO 14001, and internal IFF requirements.  See file attachments below for our most recent Responsible Care corporate certificate.

IFF has adopted what we call our "2025 Sustainability Goals" -- ambitious performance improvement goals with a broad external focus: strengthening our relationships with the communities where we operate, continuing to improve our product stewardship and innovation, and reducing our global footprint.  In support of these goals, IFF is constantly working to improve our performance through focused EH&S programs such as the Waste Reduction Always Pays (WRAP) program.

Specific to ISO-14001, IFF currently has 19 sites globally that are ISO 14001 certified.  Our other 200+ sites are not currently pursuing ISO 14001 certification from an outside body.  However, IFF's Operating Discipline Management System (ODMS) is applicable globally and complies with the requirements established in ISO-14001 and Responsible Care®.  All Dow sites globally have implemented, or are in the process of implementing their Environmental Management system consistently with this global Management System.

® Responsible Care is a Registered Service Mark of the American Chemistry Council

The manufacturing facilities in Germany (Stade, Bomlitz) are certified for Environmental Management for ISO 14001.

ETHOCEL™ utilizes a third-party drumming (final packaging) provider where the subsequent
steps are followed:

• Final packaging takes place on a dedicated line at the drumming facility where clean room concepts are practiced, and cGMP regulations are adhered to.
• Packaging personnel are required to abide by the facility’s policy for clothing and hygiene, which requires that all packaging personnel wear white gowning suits that have long sleeves and no pockets, hair and beard coverings are to be used, and clean nitrile gloves are to be worn, so that no bare skin is exposed during packaging.
• Empty drums, lids, and liners are inspected to ensure cleanliness inside the packaging room. Additional cleaning is conducted as needed or the drum is rejected
• The drum labels for a batch are printed ahead of time and are placed in the packaging room on a table. To label a drum, the Packager removes a single label from the paper backing and applies it to the drum.
• Only two drums are prepped in the room at a time to avoid potential contamination.
• A new polyethylene liner is carefully opened and placed into a new drum and put into station for filling.
• Once filling is complete, the liner is removed from the fill head; any weight adjustment is quickly made, and the drum liners are immediately sealed with zip ties. The lid is replaced and sealed with an additional zip tie. The material is sealed at time of manufacture in the packaging room and not opened thereafter.
• When the drum has been properly labelled and secured it is then placed on the conveying line out to the main warehouse for palletizing and preparation for shipment.
• Upon completion of the packaging for a batch, the packaging room is cleaned in preparation for the next batch of product.
• Palletizing involves stacking finished drums on a new heat-treated pallet with a virgin slip-sheet on top and shrink-wrapping the entirety of the material on the pallet.

When the outer lids are sealed, extraneous materials would not be able to enter the drum itself.
It is possible, however, that extraneous materials could enter the ring around the seal in some
instances. To further reduce instances of this occurring, it is suggested that when storing the
material to maintain a plastic cover and/or stretch wrapping.

Also, upon opening drums, it is suggested as a best practice, to:

• Remove the ring only from the drum first
• Inspect the ring for any potential contaminants
• Wipe down the lid thoroughly, paying close attention to where the ring forms around the lid
• Once clean, the individual may proceed with removing the lid.

The zip tie securing the ring and drum lid is considered a secondary seal mechanism. The polyethylene liner inside of the drum that is secured with a zip tie is considered the primary seal.
Therefore, if foreign materials come into contact with the secondary seal, the ETHOCEL™ product may still be considered suitable for use if the primary seal remains intact while foreign materials on the secondary seal are appropriately removed and the chance of contamination is eliminated.

We are focused on providing the highest quality product to the pharmaceutical industry and
minimization of foreign particles in our excipient grade products is an important part of this
strategy.

ETHOCEL ethylcellulose polymers are colorless, odorless, tasteless, and noncaloric. They have outstanding chemical and physical properties.  These properties make them useful in many applications - from pharmaceutical, food, and personal care applications to specialty applications, including some of the most sophisticated electronic devices.

Physical Properties^a of ETHOCEL Standard cellulose ethers

 

EPA Pesticide Inert Ingredient Public Tradename Database

The following Tradename Products are listed in the public facing trade name database (https://ordspub.epa.gov/ords/pesticides/f?p=inertfinder:mixtures) of the  Environmental
Protection Agency (EPA) with IFF as the manufacturer.

Ethocel™ Medium 70, Standard 10, Standard 100, Standard 20, Standard 200, Standard 300, Standard 4, Standard 45, Standard 7):  is currently approved for food-use under 40 CFR 180.960 as an inert   ingredient in pesticide formulations.

For the Natural Index calculated according the ISO 16128 standard, please refer to below table:

Product Class	Trade name and sub-class	Natural Content / Natural Index (%)
MC	METHOCEL™ A	87
HPMC	METHOCEL™ E	79
HPMC	METHOCEL™ F	82
HPMC	METHOCEL™ J	69
HPMC	METHOCEL™ K	84
HPMC	METHOCEL™ 311 – Affinisol HME	65
Na-CMC	TEXTURECEL™…07 *	76
Na-CMC	TEXTURECEL™…(09) *	71
Na-CMC	TEXTURECEL™…1.2 *	65
EC	ETHOCEL™ Med	76
EC	ETHOCEL™ Std.	71
MCC	Lattice® NT – all grades	100
Colloidal MCC	Lattice® NTC – all grades	91
PEO	POLYOX™ - all grades	0
Na-,K-,Ca-alginate	Scogin®, Protaweld® and Protanal® (excluding Protaweld® KLH 120)	100
Carrageenan	SeaSpen® IN and SeaSpen® 379	100

* The numbers 07 and 1.2 indicate the substitution degree 0.7 or 1.2. No respective number means the (standard) substitution degree of 0.9

• Calculations were done using a central value of the specification window, USP if possible, otherwise CE 29.1.
• Variations may occur during testing, depending on:
  • Individual batches
  • Inorganic compounds such as salts, catalysts, humidity, etc were not considered in the calculation